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Medtronic Announces FDA Submission for InterStim™ Micro Neurostimulator and SureScan™ MRI Leads

Medtronic plc (MDT) today announced it has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The SureScan™ leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval. Read more.

Source: Globe Newswire, October 7, 2019

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InterStim Incontinence and Bladder Control Implant Now Controlled via App

Medtronic won FDA approval to introduce the InterStim smart programmer to control the company’s InterStim neurostimulation system used to manage overactive bladder, bowel incontinence, and some types of urinary retention.  The InterStim system delivers sacral neuromodulation therapy via an implant that looks similar to a cardiac pacemaker.  Read more.

Medgadget, December 17, 2018